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A Guide on CDSCO Guidelines for Medical Devices in India

calendar21 Feb, 2024
timeReading Time: 5 Minutes
CDSCO Guidelines for medical devices

The Medical Devices Rules, 2017, has laid down the standards for manufacturing and importing medical devices in India. Devices exported from foreign countries such as France, China, USA, Japan, Canada, KSA, European Union, etc., must obtain valid approval and quality clearance certificates under their respective laws and regulations. The Medical Devices Rules as well as the CDSCO Guidelines for medical devices mandate that the devices imported into India must undergo requisite clinical investigations and have to procure an intended use certificate. The CDSCO guidelines for medical devices ensure that the devices manufactured or imported in India comply with internationally accepted safety and quality control standards.

Types of Medical Devices in India

Medical Devices manufactured and sold in India are classified into five different categories –

  1. Diagnostic and Imaging devices – X-ray, MRI, etc.
  2. Injectables and consumables – Syringe, Needles, Drips etc
  3. Dental Products – Braces, tooth caps, crowns, dentures
  4. Prosthetics – Crutches, artificial implants, arms, knee implants, artificial joints
  5. Patient Aids – hearing aids, pacemakers,eye lenses, etc.

Classification of Devices based on risk factor

Based on the risk involved in their usage and handling, the four categories of devices are divided into four categories –

Category A – These devices signify Low risk factor

Category B – These devices carry low to moderate risk factor

Category C –These devices fall in the moderate to high-risk category

Category D – These devices fall in High – risk category

A new circular issued on November 1, 2017, states that even the companion parts of medical equipment or their auxiliary peripherals must be categorized.

Bodies Regulating CDSCO Guidelines for Medical Devices

The Central Government has entrusted the regulation of CDSCO medical devices to the Central Drug Standard Control Organization and the State Drug Standard Control Organization, which administers the same within states and union territories. The restive central and state authorities have created separate licensing authorities to oversee the licensing procedure of these domains. They are –

The Central Licensing Authority (CLA) will have direct control over Class C and D medical device production. It will oversee and manage the importation of all medical equipment belonging to the A, B, C, and D classes. All new medical devices and in-vitro diagnostic device licenses will be approved after a clinical efficacy assessment and clearance test. It will supervise clinical studies and grant approvals for any medical equipment utilized in research.

The State Licensing Authority (SLA) will oversee the production of Class A and B medical devices. It will supervise the distribution and sale of all four classes’ worth of equipment.

CDSCO Regulatory guidelines for specific entities

Based on the commercial activity undertaken by the license-holder of a CDSCO Authorizing, i.e. manufacturer, importer, distributor, etc, The Government and CDSCO have prescribed certain forms and disclosures that need to be submitted with the regulatory authority before commencing operations. They are –

For Manufacturers –

  • An application must be completed in order to obtain a license to produce devices in Classes A and B for distribution or sale in Form MD -3.
  • An application that must be completed in order to obtain a loan license to produce devices in Classes A and B for sale or distribution in Form MD – 4.
  • An application in Form MD-5 will grant the right to manufacture Class A and B medical devices on the individual’s own manufacturing unit or premises.
  • Form MD -6 is used to obtain a license to manufacture medical devices of classes A and B on the property of other manufacturers.
  •  An application must be completed in order to obtain a license to produce devices in Classes C and D for distribution or sale in Form MD -7.
  • An application in Form MD – 8 must be completed to get a borrowing license to produce Class C and D devices for distribution or sale.
  • Form MD-9 is used to grant permission to manufacture Class C and D medical devices on the manufacturers’ premises.
  • Form MD-10 is the form used to grant licenses to manufacture Class C and D medical devices on the premises of any other manufacturers.
  • Form MD-12 and Form MD-13 are required to be filed to obtain a clinical test license.
  • In order to conduct clinical investigations of a new medical device falling under Category C and D, an application in Form MD-23 is required to be filed.

For Importers-

  • Similarly, for manufacturers, in order to conduct clinical investigations of a new medical device falling under Category C and D, an application in Form MD-23 is required to be filed.
  • To obtain a license to import medical devices for sale or distribution through an authorized agent who already holds a license for the manufacture, sale, and distribution of medical devices or a wholesale license for the same, an online application must be submitted to the Central Licensing Authority (CLA) in Form MD -14.
  • If the application complies with all requirements, an import license will be issued in Form MD-15.
  • Importers of medical devices are required to obtain a test license first in order to establish the availability of the device. The device licenses can be procured in Form MD-17 and MD-16.
  • A late payment fee equal to 2% of the licensing cost each month will be applicable to the license holder if they fail to pay the required amount by the deadline. Alternatively, they may choose to make a partial payment within 180 days. The license will be considered cancelled if the license holder continues to neglect to pay the late charge.

The process to obtain a license for CDSCO medical devices

Clinical testing of the Medical Device

In order to comply with the CDSCO Guidelines for medical devices, our specialists will first assess the class of your medical device, in vitro diagnostics device, patient aid, or consumables, along with the applicable form that needs to be filled out.

Filing of Application and necessary documentation

Prior to filling out the appropriate Forms and submitting requisite documentation to comply with the CDSCO Regulatory guidelines

for medical devices, our specialists will assess the class and type of your medical device, in vitro diagnostics devices, patient aids, or consumables.

Grant of CDSCO License

Upon satisfactory verification of the required documents and data by the relevant licensing body, the CDSCO registration for cosmetics, in vitro diagnostics, and medical devices is obtained.

LICENSE VALIDITY

If the CDSCO License fee is paid in accordance with the Second Schedule of the Medical Devices Rules, 2017, before the license’s expiration date of five years, a license, loan license issued under Form MD-5, MD-6, Form MD-9, MD-10, or import license issued under Form MD-15 will remain valid indefinitely, expect suspension or cancellation by the State or Central Licensing Authorities under any exceptional circumstances.

The CDSCO medical devices license holder will be subject to an additional late payment fee equal to 2% of the licensing fee per month or pay a portion of the license fee if they fail to pay the requisite amount by the deadline.

Conclusion

Medical apparatuses and equipment used in hospitals, dispensaries, and clinics in India have to be manufactured and imported as per CDSCO Guidelines for Medical Devices. These medical devices are manufactured as per the CDSCO Regulations and any deviations from the guidelines can lead to serious implications,concerning the health and well-being of the patients and consumers of these medical devices and paraphernalia.

You willfind whatever you need with respect to having your medical business registered at Corpbiz. Be it compliance with CDSCO guidelines for Medical Devices, or statutory clearance CDSCO medical devices, Coprbiz’s specialized advisory and licensing services can help you achieve your goal of setting -up a Medical Devices manufacturing or Distribution business in India.

Frequently Asked Questions (FAQs)

  1. How are Medical Devices regulated in India?

    Medical Devices in India are regulated by the Medical Devices Regulation Rules, 2017 Drugs and Cosmetics Act, 1940, and Rules, 1946.

  2. What are the statutory bodies that regulate medical device licensing in India?

    Medical Devices and apparatuses are licensed and regulated by the Central Drug Standard Control Organization and State Drug Control Organization. These have deputed the Central Licensing Authority and State Licensing Authority to oversee medical device licensing procedures in the country.

  3. What is the ISO Standard for Medical devices imported or manufactured in India?

    The medical devices manufactured or imported in India should conform with ISO standard 13485.

  4. What are the categories of medical devices in India as per CDSCO Regulatory Guidelines?

    There are four categories of devices based on the risk factor of use based on the CDSCO Guidelines for medical devices. They are – Category A is for devices that signify Low-risk factors; Category B is for devices that carry low to moderate risk factors; Category C – These devices fall in the moderate to high-risk category, and Category D devices fall in High – the high-risk category.

  5. What are some examples of medical devices?

    As per the CDSCO Guidelines for medical devices, X-rays, MRI scanners, Syringes, Needles, Drips, Braces, tooth caps, crowns, dentures, Crutches, artificial implants, arms, knee implants, artificial joints, hearing aids, pacemakers, eye lenses, etc.

  6. What is the procedure for import as per CDSCO Guidelines for medical devices?

    Importing medical devices into India as per the CDSCO Guidelines for medical devices requires the submission of an application, together with the required fee, to the Central Licensing Authority via Form MD-14 and the Ministry of Health and Family Welfare's SUGAM web portal. The application must be submitted through an approved agent who holds a wholesale license for sale or distribution in India or a manufacturing license for sale or distribution in India.

  7. What are the documents required as per CDSCO Guidelines for medical devices in order to obtain a medical devices license?

    As per the CDSCO Guidelines for medical devices, the documents required are the ID proof of the applicant, undertaking, address proof, and various other hard-copy documents that are required to be submitted to the local CDSCO Office. After submitting the documents, the applicant must fill out an application in the form available on the SUGAM Portal.

  8. What is the validity of a license for CDSCO Regulatory Guidelines?

    If the CDSCO License fee is paid in accordance with the Second Schedule of the Medical Devices Rules, 2017, before the license's expiration date of five years, a license, loan license issued under Form MD-5, MD-6, Form MD-9, MD-10, or import license issued under Form MD-15 will remain valid indefinitely, expect suspension or cancellation by the State or Central Licensing Authorities under any exceptional circumstances.

  9. How much time does it take to grant a CDSCO License?

    As per the CDSCO Guidelines for medical devices, an import license is granted within nine months after the application date. The importer has 45 days to file an appeal with the Central Government in case of a refusal. Following a thorough investigation and examination, the Government may issue orders within 90 days of the appeal date.

  10. How can Corpbiz help me?

    Corpbiz is a leading compliance and corporate advisory services provider, with a dedicated team of medical license professionals and consultants to help our clients with every compliance requirement. With Coprbiz, you can be assured of efficient, cost-effective, and swift CDSCO License procurement as per the CDSCO guidelines for medical devices.

Read Our Article: CDSCO Guidelines For Medical Device Import

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